New audio processor aims to help cochlear implant users hear better in noise
NCT ID NCT04918654
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the RONDO 3, a new single-unit audio processor for people with cochlear implants. It includes features like beamforming and noise reduction to help users hear speech in noisy places. Twenty experienced users participated to see if these features improve hearing and satisfaction.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RONDO 3 single-unit audio processor with automatic sound management features
- What this could lead to
- If successful, this could lead to better hearing in noisy environments for cochlear implant users, improving daily communication and quality of life.
- What could go wrong
- This is a small, completed study with only 20 participants, so results may not apply to all users. The improvements are incremental, not a breakthrough.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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20 people
The number who actually took part.
- Started
-
Jun 2021
- Finished
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Dec 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Post-lingually deafened adult cochlear implant users with a MED-EL device.
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * A minimum of 18 years old * Experienced user of a RONDO 3 (≥ 3 months) for the ear to be tested * Post-lingual onset of severe to profound sensory-neural hearing loss on the ear to be tested * A minimum of 40% speech recognition in the Freiburg Monosyllables Test in quiet at 65 dB SPL for the ear to be tested (at the last time tested in clinical routine) * Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure. Exclusion criteria * Lack of compliance with any inclusion criteria * CI user with contralateral hearing equal to or better than 30 dB (pure-tone average over the following frequencies: 250, 500, 1000, and 2000 Hz) * Implanted with C40X, or C40C on the ear to be tested * Implanted with an Auditory Brainstem Implant (ABI) or split electrode array * Known allergic reactions to components of the investigational medical device (RONDO 3) or the SONNET 2 * Anything that, in the opinion of the Investigator, would (a) place the subject at increased risk, (b) preclude the subject's full compliance with or completion of the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
MHH - Medizinische Hochschule Hannover
Hanover, 30625, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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